Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer

NCT06024356 | Unknown

• 1 other identifier: BFH-TTNCRT
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

It is a single-center, retrospective, controlled study to investigate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin for locally advanced mid-low rectal cancer.

Conditions

Colorectal Neoplasms

Keywords

Colorectal Neoplasms; Programmed Cell Death 1 Receptor; Thymalfasin; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• pathologic complete response

  All the enrolled patients will receive total mesorectal excision (TME) 7-9 weeks after the end of long course radiotherapy. The rectal specimens will be evaluated by the pathologists who are experienced on the rectal cancer diagnosis according to the 1997 Dworak grading system. The rectal cancer will be classified into 5 grades. Grade 0-3 will be considered as non-pCR while grade 4 represent pCR.

  1 year

Secondary Outcomes (8)

• neoadjuvant rectal (NAR) score

  1 year

• tumor regression grade（TRG）

  1 year

• objective response rate (ORR)

  1 year

• R0 resection rate

  1 year

• anal preservation rate

  1 year

Other Outcomes (5)

• The expression of CD86

  1 year

• The expression of CD163

  1 year

• The expression of CD4+

  1 year

Study Arms (2)

Experimental

long course radiotherapy (50 Gy/25f, 2 Gy/f, 5 days/week) for the first 5 weeks and three 21-day cycles capecitabine (1000 mg/m2, bid, po, day1-14) plus three 21-day cycles tislelizumab (200 mg, iv.gtt, day 8) for the first 9 weeks. After that, patients rested for two weeks (week 10-11)。6-8 weeks after the end of radiotherapy, patients underwent TME surgery (12-14 weeks). Thymalfasin was started on the first day of neoadjuvant chemoradiotherapy, 1.6 mg subcutaneously twice a week until the end of the last neoadjuvant treatment.

Drug: Thymalfasin

Control

long course radiotherapy (50 Gy/25f, 2 Gy/f, 5 days/week) for the first 5 weeks and three 21-day cycles capecitabine (1000 mg/m2, bid, po, day1-14) plus three 21-day cycles tislelizumab (200 mg, iv.gtt, day 8) for the first 9 weeks. After that, patients rested for two weeks (week 10-11)。6-8 weeks after the end of radiotherapy, patients underwent TME surgery (12-14 weeks).

Interventions

Thymalfasin DRUG

Thymalfasin (thymosin-alpha 1) is an immunomodulating agent able to enhance the Thl immune response. It has been evaluated for its immunomodulatory activities and related therapeutic potential in several diseases.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

locally advanced mid-low rectal cancer

You may qualify if:

• Patients with rectal adenocarcinoma must satisfied all the following conditions:
• Stage II/III LARC (cT1-4aN0-2M0);
• Tumor distal location≤10 cm from anal verge (MRI diagnosed);
• Patients regardless of gender with aged≥18 years
• ECOG score of 0 or 1
• Physical and viscera function of patients can withstand major abdominal surgery

You may not qualify if:

• Current or previous active malignancy other than rectal cancer；
• Patients underwent major surgery within 4 weeks prior to neoadjuvant therapy；
• Patients have any condition affects the absorption of capecitabine through gastrointestinal tract；
• Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
• Patients with severe concomitant diseases with estimated survival≤5 years；
• Patients with present or previous moderate or severe liver and kidney damage；
• Patients preparing for or previously received organ or bone marrow transplant；
• Patients who have received immunosuppressive or systemic hormone therapy within 1 month prior to the start of neoadjuvant therapy；
• Patients with congenital or acquired immune deficiency (such as HIV infection)；
• Pregnant or lactating women.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital medical University

Beijing, Xicheng Dis, 100050, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pathology Paraffin Sections （Pre-NCRT and Post-NCRT）

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Thymalfasin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: September 6, 2023
• Study Start: September 20, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 30, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2025.5-
• Access Criteria: via reasonable email requests

Locations

CN (1)